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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ALLURE QUADRA RF CRT-P; No Match
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ABBOTT ALLURE QUADRA RF CRT-P; No Match Back to Search Results
Model Number PM3242
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2023
Event Type  malfunction  
Event Description
During a routine device exchange, it was difficult to remove the lead from the header of the device.Following a struggle, the device and lead were able to be disconnected.A new device was successfully implanted to resolve the event.The patient was stable.
 
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Brand Name
ALLURE QUADRA RF CRT-P
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key17636104
MDR Text Key322104018
Report Number2017865-2023-40485
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734507912
UDI-Public05414734507912
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2016
Device Model NumberPM3242
Device Lot NumberA000000339
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/14/2023
Initial Date FDA Received08/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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